High dose atorvastatin in acute ischemic stroke ? Monocenter pilot study - ADIS 1.0

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000433-21-IT

Enrollment

150

Registered

2008-03-17

Start date

2008-03-04

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute ischemic stroke MedDRA version: 9.1 Level: LLT Classification code 10057613 Term: Thromboembolic stroke

Interventions

Trade Name: TORVAST*50CPR RIV 80MG PVC-AL Pharmaceutical Form: Coated tablet INN or Proposed INN: Atorvastatin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80- P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Clinical-radiological diagnosis of acute ischemic stroke 2) Onset of symptoms within 12 hours before enrolment 3) NIHSS >= 4 4) Age >= 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Inability or refusal of the patient or relative to provide the informed consent 2) Dysphagia associated with impossibility to insert a naso-gastric tube 3) Thrombolytic treatment of stroke 4) Patient already under statin treatment 5) Known statin intolerance 6) Modified Rankin Scale > 3 before the acute stroke 7) Pregnancy 8) Malignancy 9) Liver cirrhosis 10) Chronic hepatitis 11) Jaundice 12) Alcoholism 13) Acute hepatic failure 14) Concurrent treatment with cyclosporin, erythromycin, clarithromycin, itraconazole, ketoconazole, nefazodone, niacin, gemfibrozil, other derivatives of fibric acid or inhibitors of HIV proteases. 15) Baseline AST or ALT or CPK > 3 fold the maximum normal limit

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To define the premises for a larger multicenter study with similar objectives.;Primary end point(s): Primary end-point 1) NIHSS decrease >= 4 points (at 7 days) Secondary end-points 1) Brain infarct volume at CT scan (after 3 days) 2) Modified Rankin scale <=2 (at 3 months);Main Objective: To show favorable effects of the early administration of atorvastatin 80 mg/day in acute ischemic stroke, on the short term development of neurological deficit and extension of brain lesion, and on the medium term handicap degree. To define the premises for a larger multicenter study with similar objectives.	—

Measure

Time frame

Secondary Objective: To define the premises for a larger multicenter study with similar objectives.;Primary end point(s): Primary end-point 1) NIHSS decrease >= 4 points (at 7 days) Secondary end-points 1) Brain infarct volume at CT scan (after 3 days) 2) Modified Rankin scale <=2 (at 3 months);Main Objective: To show favorable effects of the early administration of atorvastatin 80 mg/day in acute ischemic stroke, on the short term development of neurological deficit and extension of brain lesion, and on the medium term handicap degree. To define the premises for a larger multicenter study with similar objectives.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026